EUCTR2011-003618-18-CZ
Active, not recruiting
Not Applicable
A Randomized, Double-Blind, Phase 2, Dose-RangingStudy to Evaluate the Safety and Efficacy ofVeliparib and Whole Brain Radiation Therapy VersusPlacebo and Whole Brain Radiation Therapy inSubjects with Brain Metastases from Non-Small CellLung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain metastases from NSCLC
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Enrollment
- 330
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject must be \= 18 years of age;
- •Subject must have cytologically or histologically confirmed NSCLC;
- •Subject must have brain metastases as demonstrated on a MRI brain scan;
- •Subject must be eligible for WBRT;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 80
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 250
Exclusion Criteria
- •Subject was diagnosed with brain metastasis \>28 days prior to Treatment Day 1;
- •Subject received any prior form of cranial radiation and/or neurosurgery for brain metastasis;
- •Subject has a Karnofsky Performance Score (KPS) of \< 70;
- •Subject has significant dyspnea requiring supplemental oxygen therapy;
- •Subject has liver metastases (restaging is not required for known liver metastasis);
- •Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following: intra\-cranial sites of metastasis from NSCLC, thoracic sites of metastasis from NSCLC, and bone metastasis;
- •Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a baseline MRI brain scan;
- •Subject's last dose of chemotherapy or investigational therapy was \= 7 days prior to Treatment Day 1;
- •Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti\-cancer treatment;
- •Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastasis are eligible however he/she should receive adequate anti\-seizure medication prior to study treatment;
Outcomes
Primary Outcomes
Not specified
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